Diagnostic Tests

News & Analysis as of

Media gulled by prostate cancer study hyped by Windy City windbags

A well-known research university and some excitable journalists have sown confusion about prostate cancer and the value of the PSA screening test. The mess can be traced to a study by physicians from Northwestern University...more

Wearable Medical Devices Market Trending Upwards

New reports, such as the Global Diagnostic Wearable Medical Devices Market 2016-2020 Report, bring good news to the rapidly growing wearable medical device market. According to the Report, the diagnostic wearable medical...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft...more

CMS Releases Final Rule Implementing Reforms to Medicare CLFS Payment Rates Under PAMA

On June 23, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule implementing Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which established a new payment methodology for...more

Summary: PAMA Final Rule

Market Based Payment for Clinical Diagnostic Laboratory Tests - Summary - On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more

Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility...

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic...more

CMS Finalizes Changes to Medicare Clinical Lab Test Payment Policy, Pushes Back Effective Date to 2018

On June 23, 2016, the Centers for Medicare & Medicaid Services (CMS) is publishing a major final rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts, as required by...more

First-Ever FDA Approval of Liquid Biopsy for Detecting Lung Cancer

The New York Times reports that Roche, a Swiss biotech company, recently received the first-ever FDA approval for a “liquid biopsy” test for diagnosing non-small cell lung cancer (NSCLC).  The Times reports that while the...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more

CMS Announces July 18 Public Meeting on 2017 Medicare Clinical Lab Fee Schedule

CMS has scheduled a July 18, 2016 public meeting on payment for new and substantially revised clinical diagnostic laboratory test codes for payment under the 2017 Medicare clinical laboratory fee schedule (CLFS). The meeting...more

Superman Breyer v. Batman Lourie Battle in the Sequenom Petition for Cert.

Since this is an amplification of my last post on the Sequenom petition for cert. in Sequenom v. Ariosa, please go back at read my first post on the petition. I have been arguing for some years that the patent world will...more

Infrastructure Investments Rule in Q3

Our analysis of digital health investment in the third quarter of 2015 revealed that just under $3 billion was invested in the sector and more than half of that went to infrastructure providers....more

Federal Circuit Expresses Concern About Patent Eligibility Under Mayo

The “prognosis” for patentability of medical diagnostic claims remains uncertain after an order of the Federal Circuit Court of Appeals (“Court”) denying a petition for an en banc rehearing of its decision in Ariosa...more

Federal Circuit denies en banc review of Ariosa v. Sequenom

On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in...more

Misdiagnosis and Traumatic Brain Injuries

How often do diagnostic errors occur, and should individuals with traumatic brain injuries (TBIs) be particularly concerned about the risks associated with misdiagnosis? According to a fact sheet from RightDiagnosis.com, TBIs...more

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

FDA Invites Genome Scientists to Come Play in the precisionFDA “Sandbox” - NGS Technologies Take Center Stage at Agency Campus

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more

Upcoming Health Policy Hearings - November 2015

Several Congressional hearings are scheduled next week and into December on health policy issues, including...more

Also In The News - Health Headlines - November 2015

CMS Publishes Medicaid Access Final Rule – CMS published a Final Rule in the Federal Register today, November 2, 2015, that implements a process for states to determine whether Medicaid payments satisfy what is known as the...more

Why Patients Should Fear Diagnostic Errors

Errors in diagnosis are the top cause for medical malpractice lawsuits in the United States. Despite these staggering statistics, diagnostic errors have not been the subject of attention in Chicago the way that other...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

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